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Retrospective, Non-interventional Database Study for the Evaluation of Real-world Drug Use Patterns, Clinical Characteristics and Clinical Outcomes in Patients Initiated on Vericiguat in India
This is an observational study in which data already collected from people with chronic HFrEF (heart failure with reduced ejection fraction) who have experienced worsening heart failure are studied. Chronic HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and even death. The study drug, vericiguat, is already approved for doctors to prescribe to people with worsening of heart failure with chronic HFrEF in India. Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels, allowing more blood to flow through. As a result, the heart is able to pump better. The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors. There is currently limited real-world data on the use of vericiguat. Furthermore, discussing whether vericiguat treatment should start early in people with heart failure can help doctors manage these people better. The main purpose of this study is to collect information about how well vericiguat works and how safe it is in Indian people with chronic HFrEF who have experienced worsening heart failure. To do this, researchers will collect the following information: * participants' characteristics, including age, sex, height, weight, and medical history * additional medicines participants have taken with vericiguat * other treatment options participants have taken for the treatment of heart failure * levels of NT-pro BNP\* in participants' blood at least one month before taking vericiguat (\*NT-proBNP is made by heart muscles. People with heart diseases have increased levels of NT-proBNP in their blood. Measuring NT-proBNP levels in the blood can help doctors identify heart disease.) * number of participants from India, divided into four zones-North, South, East, and West * categorization of participants based on how heart failure limits physical activity and classification of heart failure by cause * change in heart function measured by how much blood the left side of the heart can pump out * number of hospitalizations and number of participants who died due to heart-related and non-heart-related events * number of participants who experienced low blood pressure or fainting after starting treatment with vericiguat * participants who discontinued treatment with vericiguat, due to low blood pressure or fainting The data will come from the participants' hospital, medical and electronic healthcare records. Data collected will be from Indian people with chronic HFrEF who started taking vericiguat between September 2022 and August 2023. Researchers will track participants' data and will follow them until Feb 2024. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Many locations
Multiple Locations, India
Start Date
September 8, 2025
Primary Completion Date
April 30, 2026
Completion Date
April 30, 2026
Last Updated
March 19, 2026
1,200
ESTIMATED participants
Vericiguat (Verquvo, BAY1021189)
DRUG
Lead Sponsor
Bayer
NCT05093933
NCT06697353
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06363110